FDA: soliciting public input… BUT.. WILL THEY LISTEN ?

FDA Commissioner Asks Staff for ‘More Forceful Steps’ to Stem the Opioid Crisis

blogs.fda.gov/fdavoice/index.php/2017/05/fda-commissioner-asks-staff-for-more-forceful-steps-to-stem-the-opioid-crisis/

By: Scott Gottlieb, M.D.

As Commissioner, my highest initial priority is to take immediate steps to reduce the scope of the epidemic of opioid addiction. I believe the Food and Drug Administration continues to have an important role to play in addressing this crisis, particularly when it comes to reducing the number of new cases of addiction.

Dr. Scott GottliebToday, I sent an email to all of my colleagues at FDA, sharing with them the first steps I plan to take to better achieve this public health goal. With this, my first post to the FDA Voice blog, I also wanted to share my plans with you.

I believe it is within the scope of FDA’s regulatory tools – and our societal obligations – to take whatever steps we can, under our existing legal authorities, to ensure that exposure to opioids is occurring under only appropriate clinical circumstances, and for appropriate patients.

Patients must be prescribed opioids only for durations of treatment that closely match their clinical circumstances and that don’t expose them unnecessarily to prolonged use, which increases the risk of opioid addiction. Moreover, as FDA does in other contexts in our regulatory portfolio, we need to consider the broader public health implications of opioid use. We need to consider both the individual and the societal consequences.

While there has been a lot of good work done by FDA to date, and many people are working hard on this problem, I have asked my FDA colleagues to see what additional, more forceful steps we might take.

As a first step, I am establishing an Opioid Policy Steering Committee that will bring together some of the agency’s most senior career leaders to explore and develop additional tools or strategies FDA can use to confront this crisis.

I have asked the Steering Committee to consider three important questions. However, the Committee will have a broad mandate to consider whatever additional questions FDA should be seeking to answer. The Committee will solicit input, and engage the public. I want the Committee to go in whatever direction the scientific and public health considerations leads, as FDA works to further its mandate to confront the crisis of opioid addiction.

The initial questions I have tasked the Steering Committee to answer are:

  1. Are there circumstances under which FDA should require some form of mandatory education for health care professionals, to make certain that prescribing doctors are properly informed about appropriate prescribing recommendations, understand how to identify the risk of abuse in individual patients, and know how to get addicted patients into treatment?
  2. Should FDA take additional steps, under our risk management authorities, to make sure that the number of opioid doses that an individual patient can be prescribed is more closely tailored to the medical indication? For example, only a few situations require a 30-day supply. In those cases, we want to make sure patients have what they need. But there are plenty of situations where the best prescription is a two- or three-day course of treatment. So, are there things FDA can do to make sure that the dispensing of opioids more consistently reflects the clinical circumstances? This might require FDA to work more closely with provider groups to develop standards for prescribing opioids in different clinical settings.
  3. Is FDA using the proper policy framework to adequately consider the risk of abuse and misuse as part of the drug review process for the approval of these medicines? Are we doing enough when we evaluate new opioid drugs for market authorization, and do we need additional policies in this area?

These are just some of the questions I will be asking this new Steering Committee to consider right away, given the scope of the emergency we face. In the coming days, I’ll continue to work closely with the senior leadership of FDA. I want to know what other important ideas my colleagues at FDA may have, so that we can lean even further into this problem, using our full authorities to work toward reducing the scope of this epidemic.

Despite the efforts of FDA and many other public health agencies, the scope of the epidemic continues to grow, and the human and economic costs are staggering. According to data from CDC and SAMHSA, nearly 2 million Americans abused or were dependent on prescription opioids in 2014, and more than 1,000 people are treated in emergency departments each day due to misusing prescription opioids.

Opioid overdose deaths involving prescription opioids have quadrupled since 1999. In 2015, opioids were involved in the deaths of 33,091 people in the United States. Most of these deaths – more than 22,000 (about 62 people per day) – involved prescription opioids.

We know that the majority of people who eventually become addicted to opioids are exposed first to prescription opioids. One recent study found that in a sample of heroin users in treatment for opioid addiction, 75% of those who began abusing opioids in the 2000s started with prescription opioid products.

This March, a study published in CDC’s Morbidity and Mortality Weekly Report, found that opioid-naïve patients who fill a prescription for a one-day supply of opioids face a 6% risk of continuing their use of opioids for more than one year. This study also found that the longer a person’s first exposure to opioids, the greater the risk that he or she will continue using opioids after one, or even three years. For example, when a person’s first exposure to opioids increases from one day to 30 days, that person’s likelihood of continuing to use opioids after one year increases from 6% to about 35%.

Working together, we need to do all we can to get ahead of this crisis. That’s why we’ll also be soliciting public input, through various forums, on what additional steps FDA should consider. I look forward to working closely with my FDA colleagues as we quickly move forward, capitalizing on good work that has already been done, and expanding those efforts in novel directions. I will keep you updated on our work as we continue to confront this epidemic.

Scott Gottlieb, M.D., is Commissioner of the U.S. Food and Drug Administration

Follow Commissioner Gottlieb on Twitter @SGottliebFDA

9 Responses

  1. Why isn’t it also stated that both Congress and other Political Representatives have written Themselves Out Of This ??? These Denials for people with painful Chronic illness only apply to a select group, NOt CONGRESS, AND POLITICAL REPS, WHO DONT HAVE TO WORRY, BECAUSE THIS OPIATE RESTRICTION DOES NOT AFFECT THEM……WHY ?????? AND WHAT IS THEIR REASON FOR BEING EXCLUDED FROM THE PAIN, SUFFERING, AND SUICIDE THAT “THE COMMON” PEOPLE ARE BEING SUBJECTED-TO ??

  2. I will be making a comment, but I doubt they’ll even read it. Hopefully, many people will reach out and make their comments, too. I’m literally sick of the pure ignorance of these people … or maybe it’s pure greed. These vile pieces of s**t will one day have to answer to God and explain why their love of money was more important than human lives. Hopefully, they’ll experience some karma in action here on earth before answering to God.

  3. I am, along with the 100 millions of other Americans, are on the other end of opioids. I am one of these 100 million Americans who have chronic incurable pain disease. As the CDC, DEA and Medicaid and medicare, and numerous other government associates, are blaming Dr’s for the over prescribing of medication, NOBODY, is looking at or reading the statistics from chronic pain disease patients. How about not addressing these drugs as dangerous and addictive. Let’s look at them as lifesaving and medically necessary for the million of Americans with a chronic disease? Chronic pain is a disease. It is now becoming an epidemic.
    No other disease medication is scrutinized. We as patients are being denied, dismissed and overlooked by our drs due to all the scrutiny associated with treating chronic pain disease. Our Dr’s are afraid to treat us adequately. We have a disease that medication is readily accessible to us and we are being denied. We pain patients are truly being discriminated against, due to people who have used heroin, illegal fentanyl, and placed a blame on anyone but themselves. This is a witch hunt for Dr’s who prescribe life saving medication for pain disease patients who benefit from this medication.
    We have a chronic disease. We want to be able to take care of our homes, our children, our selves, as much as possible, but without access to these life saving medications, we are unable to do so. We want to live not just exist in pain 24/7.
    We need the government agencies to look at the real statistics, not the hand picked.
    We need help. With all the headlines, topics and stories on how opioids are bad, let’s look at what good they do for our disease of chronic pain and the million of Americans they help.

  4. I would like to know details of all these studies etc. where he is getting his info from. From what I have read, his numbers are way off. Why are so many people jumping on this band wagon, for votes?, or some sort of “celebrity” status? Nothing is ever said about pain patients, or the fact that most of these drugs are counterfeit, illegal street drugs that have nothing to do with doctors or patients. Some experts have said in their 30+ years of helping addicts, not one said legal prescribed medication got them hooked on heroin, more likely alcohol got them started with partying and went from there. There is enough of this hysteria, where are all the outraged officials looking out for our interests?

  5. Judging by the idiotic statements and ridiculous numbers he’s quoting anyone now or in the future who suffer severe chronic pain is screwed! The man has made up his mind! Why can’t these idiots see that attempting to legislate away drug addiction doesn’t do anything but hurt people who are innocent of wrongdoing? Addicts don’t give a dam what the law says, they will get there drug of choice or an alternative! They don’t care about the consequences of their actions will be for themselves or anyone else! Mary is right, we are dead. When I can no longer take the pain and feel that my only way out is death I will have my husband or son pay for a full page in the Washington post and post a letter there that will leave no question as to why I chose such a drastic way to escape my pain!! Reading this made me actually physically ill! God help us all!!!

    • Ditto Connie,,,consciderring Mr.Lawhern and Dr.Cheek were just up there,,talking to the fda ,”panel,” telling them the real truth as to what is happening out here,,to us,,,it appear’d they heard NOTHING these 2 very very educated people stated…U know big picture,,,all these restriction are based upon academic,,,,not fact or experience…Like dumbo a gooo,,klondyn stating heroin feels like oxycodone,,,has he ever taken heroin??/NOOO,, of course not,,so its opinion,,not fact,,the he feels heroin feels like oxycodone,,this soo far gone,,,as us cpp’s know,,we never ,”feel,” any kind of euphoria from our medicine,,except that of our physical pain lessened,,,THATS IT!@!WERE THE WALKING DEAD PEOPLE,,,,,,JMO,,maryw

  6. We are in more trouble people if his ,”thoughts,” turn into law..These abuse of power idiots,,,think that medical testing shows ALL,,that X-RAYS,MRI’S CATCH EVERYTHING,,and in my case they obvuiosly don’t,,,,,Where do we write this idiot,,and does anyone know if he is a actual doctor???With doctors lieing all over patients records,,calling us ltd’s or addicts to justify discharging some,,,all their data is corrupt and wrong,,,,,,,,Boy if we don’t stop this Moran we will all be dead,,,maryw

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